A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: plazomicin; Drug: metformin

• Registration Number: NCT03270553
• Lead Sponsor: Achaogen, Inc.

Brief Summary

This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Study Start: 2017-08-31
• Study First Posted: 2017-09-01
• Status Verified: 2017-10
• Primary Completion: 2017-10-07
• Study Completion: 2017-10-07
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings

Key

Exclusion Criteria

• Estimated creatinine clearance <90 mL/min
• Use of tobacco- or nicotine-containing products
• History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
• History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness
• History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	metformin	In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
Sequence 2	plazomicin	In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone
Sequence 1	plazomicin	In Period 1, subjects receive metformin alone; in Period 2, subjects receive metformin + plazomicin
Sequence 2	metformin	In Period 1, subjects receive metformin + plazomicin; in Period 2, subjects receive metformin alone

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of metformin in plasma	9 days

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	15 days
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)	8 days
Pharmacokinetics of plazomicin in plasma	9 days
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)	9 days
Pharmacokinetics of metformin in urine	9 days

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Lincoln, Nebraska, United States